# K182589: BD Plastipak Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 14, 2019 after 175 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980987 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 4.

## Most influential descendants
- K230235: Medline Luer Lock Syringes (2024), 0 descendants of its own

## Indications for use
The BD Plastipak™ Syringe is intended for single use by health care professionals for general purpose fluid aspiration/injection.

Source page: https://510kreport.com/device/K182589
Methodology: https://510kreport.com/methodology